FORMULATION AND EVALUATION OF ORAL SOFT GEL OF METFORMIN
Author (s): Mukesh.C. Gohel1, Rajesh K. Parikh1, Subhankari Mishra2, Ashutosh Mohapatra3*
The formulation of dosage forms now more oriented towards ease of administration and with good patient compliance. The drug of choice for non-insulin-dependent (Type-2) diabetes mellitus is orally administered Metformin hydrochloride. Geriatric and Paediatric subjects do exhibit Dysphagia (difficulty in swallowing). Most commonly patients Type 2 diabetes exhibit dysphagia. With a motto of providing an alternate and patient compliant dosage form of Metformin various batches of batches oral soft gel of metformin was formulated. The polymers used in the formulations were taken in two different concentrations of 0.2-0.4% w/v for gellan gum and 0.3-0.5% w/v for sodium citrate. The prepared formulation batches were evaluated for various parameters like viscosity, pH, drug content, syneresis and in vitro drug release. The batch formulated with gellan gum (0.4% w/v ratio) and sodium citrate at 0.5% concentration released drug about 85% within 15 minutes and exhibited all organoleptic properties in acceptable range. nonnutritive sugar and flavors were added to carry out taste Masking. Cold condition of stability study at 0-8 ⁰C and short term stability study at room temperature for the optimized batch showed promising results. The formulation was packed as unit dose to prevent dosing error.
Keywords: Metformin hydrochloride, gellan gum, oral soft gel.